Investors, patients and activists, no doubt, hope they won't have to put out a mayday distress call, but as Dendrama's fate would have it, the company announced today that the Food and Drug Administration has assigned May Day as its decision day for the prostate cancer treatment Provenge. Read More
Earlier this week I reported that Dr. Allen Taylor who ran the Abbott vs. Merck cholesterol drug study, which Abbott's drug Niaspan won, would only say that ABT has paid him more than $10,000 in lecture and consulting fees. But he wouldn't be any more specific than that. Read More
VVUS this morning unveiled positive late-stage test results on the ED pill. The company touts that it takes effect in less than 30 minutes and it's out of your system within six hours or so. Read More
When I do an interview with a clinical trial investigator I typically try to take care of what I call the "housekeeping" at the beginning or end. Read More
It doesn't always happen, but there is a common to-and-fro, push-and-pull, back-and-forth or whatever you want to call it between reporters and corporate PR folks. I don't particularly like that part of my job, but sometimes it just comes with the territory. I've got my job to do and they've got theirs. I get it. Read More
Today starts a two-day FDA public hearing in Washington, DC on biopharma and social media. I decided not to go because talking heads in a meeting room just don't make for good TV. And this is just the first step in what is no doubt going to be a very long, involved policy-making process. But as it turns out, it looks like it might have been futile for me to try to attend anyway. Read More
When I went to the FDA's Web site today I was surprised to see on the homepage a link to a letter written by Commissioner Dr. Peggy Hamburg. It's addressed to "Dear Healthcare Professional" aka a "Dear Doctor letter." That's a common type of communication from the agency and/or companies to the medical community, usually when they've got bad news to pass along about a drug or device. It's pretty rare for the commish to write one. Read More
Many analysts, lobbyists and industry executives have been saying for months that healthcare reform would probably end up being a net positive for the drug companies. Read More
Stacy and Clinton definitely had nothing to do with it, but Sanofi-Pasteur (the vaccines division of Sanofi-Aventis) greets visitors with a "What Not To Wear" brochure. Read More